All Liquid Products Manufactured by Pharmatech LLC and Distributed by Leader Brand, Major Pharmaceuticals, and Rugby Laboratories 

On 08/10/2017 PharmaTech LLC recalled the products listed below due to possible contamination. The U.S. Food and Drug Administration (FDA) has issued a recall Class I of the affected medications. More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

LEADER BRAND

Recalled Drug: Liquid Multivitamin Supplement for Infants and Toddlers 50 mL

                           Liquid Vitamin D Supplement for Breastfed Infants 400 IU 50 Ml

NDC/UPC Number: 096295128611, 096295128628

Lot Numbers: All Lot Numbers

Expiration Date: All Expiration Dates

MAJOR PHARMACEUTICALS

Recalled Drug:  Certa-Vite Liquid 236ML, Poly-Vita Drops 50ML , Poly-Vita Drops W/Iron 50ML , Ferrous Drops Iron Supp 50ML , D-Vita Drops 50ML , Tri-Vita Drops 50ML, Senna Syrup 237ML
NDC Number: 00904-5023-09, 00904-5099-50, 00904-5100-50, 00904-5100-50, 00904-6060-50, 00904-6273-50, 00904-6274-50, 00904-6289-09
Lot Numbers: All Lot Numbers
Expiration Date: All Expiration Dates

RUGBY LABORATORIES

Recalled Drug:  C Liquid 500mg 118ML , Diocto Liquid 50mg/5ml 473ML , Ferrous Sulfate Elixir 473ML, Fer Iron Liquid 50ML 50ML , Senexon Liquid 237ML , Diocto Syrup 60MG/15ML 473ML , Aller Chlor Syrup   120ML, Calcionate Syrup ,Cerovite Liquid 236ML, D3 400iu Liquid 50ML , Poly-Vitamin Liquid 50ML , Tri-Vitamin Liquid 50ML , Poly-Vitamin W/Iron Liquid 50ML

NDC Number: 00536-0160-97 00536-2770-85, 00536-2790-59,00536-8400-80, 00536-8450-80, 00536-8501-80, 00536-8530-80, 00536-0590-85, 00536-0650-85, 00536-0710-80, 00536-1000-59, 00536-1001-85, 00536-1025-47

Lot Numbers: All Lot Numbers

Expiration Date: All Expiration Dates

What you should do:

  • Do not continue to use any of the above medications listed if it has been recalled
  • Check your prescription label to see if you have any of the indicated medication listed above of the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from.
  • Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178. 

Diocto Liquid and Diocto Syrup

On August 2, 2017, PharmaTech, LLC recalled all lot numbers of Diocto Liquid and Diocto Syrup (NDC# 0536-0590-85 & 0536-1001-85) due to a risk of product contamination with Burkholderia cepacia, and the potential for infection. The U.S. Food and Drug Administration (FDA) has issued a Recall Class 1 of the affected medications.

More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: Diocto Liquid and Diocto Syrup
NDC Number: NDC 0536-0590-85
Lot Numbers: All
Expiration Date: All

What you should do:

  • Do not continue to use Diocto Liquid and Diocto Syrup if it has been recalled
  • Check your prescription label to see if you have Diocto Liquid and Diocto Syrup of the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from.
  • Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.


DIVALPROEX SODIUM

On August 9, 2017 Cadila Healthcare Ltd, recalled (see FDA URL below) of DIVALPROEX SODIUM (NDC#68382-031-01, 68382-032-01, 68382-032-05, 68382-033-01, 68382-033-05) Due to failure to dissolve appropriately, affecting the dose a patient may receive.

The U.S. Food and Drug Administration (FDA) has issued a Class II of the affected medications. More information about the recall is at:  http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: DIVALPROEX SODIUM 125mg, 250mg, and 500mg
NDC Number: 68382-031-01, 68382-032-01, 68382-032-05, 68382-033-01, 68382-033-05
Lot Number: To verify affected lot numbers and expiration dates please refer to FDA website at: https://www.accessdata.fda.gov/scripts/ires/index.cfm
Expiration Date: To verify affected lot numbers  and expiration dates please refer to FDA website at: https://www.accessdata.fda.gov/scripts/ires/index.cfm

What you should do:

  • Do not continue to use DIVALPROEX SODIUM if it has been recalled
  • Check your prescription label to see if you have DIVALPROEX SODIUM of the affected lot numbers and expiration dates.
  • If you have the medication, contact the pharmacy that you received it from.
  • Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

 

EpiPen (epinephrine injection, USP) and EpiPen Jr® (epinephrine injection, USP) Auto- Injectors

On 03/31/2017, Mylan recalled lot numbers (5GN767, 5GN773, 5GM631, 5GM640, 6GN215, 6GM082, 6GM072, 6GM081, 6GM088, 6GM199, 6GM091, 6GM198, 6GM087) of EpiPen (epinephrine injection, USP) and EpiPen Jr® (epinephrine injection, USP) Auto-Injectors (NDC# 49502-501-02, 49502-500-02) for failure to activate the device due to a potential defect.

The U.S. Food and Drug Administration (FDA) has issued a Class I of the affected medications. More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled products is listed below:

Recalled Drug: EpiPen (epinephrine injection, USP) and EpiPen Jr® (epinephrine injection, USP) Auto-Injectors
NDC Number: 49502-501-02, 49502-500-02
Lot Numbers: 5GN767, 5GN773, 5GM631, 5GM640, 6GN215, 6GM082, 6GM072, 6GM081, 6GM088, 6GM199, 6GM091, 6GM198, 6GM087
Expiration Date: Apr-17, May-17, Sep-17, Oct-17

What you should do:

  • Do not continue to use EpiPen (epinephrine injection, USP) and EpiPen Jr® (epinephrine injection, USP) Auto-Injectors if it has been recalled
  • Check your prescription label to see if you have EpiPen (epinephrine injection, USP) and EpiPen Jr® (epinephrine injection, USP) Auto-Injectors.
  • If you have the medication, contact the pharmacy that you received it from.
  • Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.


Oxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL

On 01/18/2017, VistaPharm recalled (Lot Numbers: 427900, 426700, 424800, 423600, 420800, 416300, 407700, 407300, 405900, 403900, 426900, 404700, 390200) of Oxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL (NDC# 66689-401-50, 66689-403-16), the purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.

The U.S. Food and Drug Administration (FDA) has issued a Class II of the affected medications. More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: Oxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL
NDC Number: 66689-401-50, 66689-403-16
Lot Numbers: 427900, 426700, 424800, 423600, 420800, 416300, 407700, 407300, 405900, 403900, 426900, 404700, 390200
Expiration Date: 11/17, 10/17, 09/17, 08/17, 06/17, 05/17, 02/17

What you should do:

  • Do not continue to use Oxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL if it has been recalled
  • Check your prescription label to see if you have Oxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL.
  • If you have the medication, contact the pharmacy that you received it from.
  • Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

GlucaGen HypoKit (glucagon [rDNA origin] for injection)

On 09/08/2016, Novo Nordisk recalled (FS6X270, FS6X296, FS6X538, FS6X597, FS6X797, FS6X875) of GlucaGen HypoKit (glucagon [rDNA origin] for injection) (NDC# 0169-7065-15) Defective delivery system: detached needles on the syringe in the kit.

The U.S. Food and Drug Administration (FDA) has issued a Class I of the affected medications. More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: GlucaGen HypoKit (glucagon [rDNA origin] for injection).
NDC Number: 0169-7065-15
Lot Numbers: FS6X270, FS6X296, FS6X538, FS6X597, FS6X797, FS6X875
Expiration Date: 9/30/2017

What you should do: 

  • Do not continue to use GlucaGen HypoKit (glucagon [rDNA origin] for injection) if it has been recalled.
  • Check your prescription label to see if you have GlucaGen HypoKit (glucagon [rDNA origin] for injection).
  • If you have the medication, contact the pharmacy that you received it from.
  • Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.

Senna Syrup (sennosides) 8.8 mg, 8 fl. oz. (237 mL) bottle

On 8/8/2016, Major Pharmaceuticals recalled Senna Syrup (sennosides) Syrup (NDC# 0904-6289-09). This recall was initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.

The U.S. Food and Drug Administration (FDA) has issued a Class II of the affected medications. More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: Senna Syrup (sennosides) 8.8 mg
NDC Number: 0904-6289-09
Lot Number: 20391517, 20391518, 20391519, 20391601, 20391602, 20391604, 20391605, 20391608.
Expiration Date: 09/17, 10/17, 11/17, 01/18, 02/18, 03/18, 06/18.

What you should do:

  • Do not continue to use Senna Syrup (sennosides) if it has been recalled
  • Check your prescription label to see if you have Senna Syrup (sennosides).
  • If you have the medication, contact the pharmacy that you received it from.
  • Adverse events from the use of prescription drugs should be reported to FDA by visiting
  • www.fda.gov/medwatch/report.htm or calling  1-800-FDA-0178.

Senexon Liquid (sennosides) 8.8 mg, 8 fl oz. (237 mL)

On 8/8/2016, Rugby Laboratories recalled Senexon Liquid (sennosides) (NDC# 0536-1000-59). This recall was initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.

The U.S. Food and Drug Administration (FDA) has issued a Class II of the affected medications. More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: Senexon Liquid (sennosides) 8.8 mg
NDC Number: 0536-1000-59

What you should do:

  • Do not continue to use Senexon Liquid (sennosides) 8.8 mg if it has beenrecalled
  • Check your prescription label to see if you have < Senexon Liquid (sennosides) 8.8 mg.
  • If you have the medication, contact the pharmacy that you received it from.
  • Adverse events from the use of prescription drugs should be reported to FDA by visiting
  • www.fda.gov/medwatch/report.htm or calling  1-800-FDA-0178.

Diocto Syrup (docusate sodium), 60 mg/15 mL

On 8/8/2016, Rugby Laboratories recalled Diocto Syrup (docusate sodium), 60 mg/15 mL (NDC# 0536-1001-85). This recall was initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.

The U.S. Food and Drug Administration (FDA) has issued a Class II of the affected medications. More information about the  recall  is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: Diocto Syrup (docusate sodium), 60 mg/15 mL
NDC Number: 0536-1001-85

What you should do:

  • Do not continue to use Diocto Syrup (docusate sodium), 60 mg/15 mL if it has beenrecalled
  • Check your prescription label to see if you have Diocto Syrup (docusate sodium), 60 mg/15 mL.
  • If you have the medication, contact the pharmacy that you received it from.
  • Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling  1-800-FDA-0178.

Sennazon (sennosides) Syrup, 8.8 mg, 8 fl. oz. (237 mL) bottle

On 8/8/2016, Bayshore Pharmaceuticals recalled Sennazon (sennosides) Syrup (NDC# 76518-100-08). This recall was initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.

The U.S. Food and Drug Administration (FDA) has issued a Class II of the affected medications. More information about the recall is at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: Sennazon (sennosides) Syrup
NDC Number: 76518-100-08

What you should do:

  • Do not continue to use Sennazon (sennosides) Syrup if it has been recalled
  • Check your prescription label to see if you have Sennazon (sennosides) Syrup.
  • If you have the medication, contact the pharmacy that you received it from.
  • Adverse events from the use of prescription drugs should be reported to FDA by visiting
  • www.fda.gov/medwatch/report.htm or calling  1-800-FDA-0178.


Albuterol Sulfate Syrup, 2 mg/ 5 mL, 473 mL bottle

On 06/22/2016, Teva Pharmaceuticals recalled Lot # 95113 of Albuterol Sulfate Syrup, 2 mg/ 5 mL, 473 mL bottle (NDC# 0093-0661-16) due to the presence of foreign substances; presence of black particles described generically as cellulose-based bundles of brown fibrous material.

The U.S. Food and Drug Administration (FDA) has issued a Recall Class II of the affected medications. More information about the recall can be found at: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.

The detailed information of the recalled product is listed below:

Recalled Drug: Albuterol Sulfate Syrup, 2 mg/ 5 mL
NDC Number: 0093-0661-16
Lot Numbers: 95113
Expiration Date: 01/2017

What you should do:

  • Do not continue to use Albuterol Sulfate Syrup, 2 mg/ 5 mL if it has beenrecalled
  • Check your prescription label to see if you have Albuterol Sulfate Syrup, 2 mg/ 5 mL.
  • If you have the medication, contact the pharmacy that you received it from.
  • Adverse events from the use of prescription drugs should be reported to FDA by visiting www.fda.gov/medwatch/report.htm or calling 1-800-FDA-0178.