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Class II: temporary or reversible health riskTerminated

Bayshore Pharmaceuticals Metformin Hydrochloride Extended-Release Recall

Metformin Hydrochloride Extended-Release Tablets USP, 750 mg 100 Tablets Rx Only Manufa…

BAYSHORE PHARMACEUTICALS · Short Hills, NJ

Risk level
Class II
Reported by FDA
Sep 2, 2020
Recall ID
D-1544-2020
Check your lot numberHow we source this data

Summary

Bayshore Pharmaceuticals recalled Metformin Hydrochloride Extended-Release starting Aug 19, 2020. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1544-2020 on Sep 2, 2020. Reason: CGMP Deviations. Status: Terminated.

Why it was recalled

CGMP Deviations

Product description

Metformin Hydrochloride Extended-Release Tablets USP, 750 mg 100 Tablets Rx Only Manufactured by: Beximco Pharmaceuticals, LTD. 126, Kathaldia, Tongi, Gazipur, 1711, Bangladesh NDC 76385-129-01

Lot numbers, UPCs & expiration codes

Lot #18657, Exp. 05/2021

Where it was sold

nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-1544-2020
Classification
Class II
Status
Terminated
Recall initiated
Aug 19, 2020
FDA report date
Sep 2, 2020
Quantity
3984 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
BAYSHORE PHARMACEUTICALS

Original FDA data

Every field from FDA enforcement report D-1544-2020, exactly as published.

Show all FDA fields
City
Short Hills
State
NJ
Status
Terminated
Country
United States
Event ID
86280
Address
788 Morris Tpke Ste 200
Code information
Lot #18657, Exp. 05/2021
Postal code
07078-2634
Report date
Sep 2, 2020
Product type
Drugs
Recall number
D-1544-2020
Classification
Class II
Recalling firm
BAYSHORE PHARMACEUTICALS
Product quantity
3984 bottles
Termination date
Apr 26, 2021
Reason for recall
CGMP Deviations
Voluntary / mandated
Voluntary: Firm initiated
Product description
Metformin Hydrochloride Extended-Release Tablets USP, 750 mg 100 Tablets Rx Only Manufactured by: Beximco Pharmaceuticals, LTD. 126, Kathaldia, Tongi, Gazipur, 1711, Bangladesh NDC 76385-129-01
Distribution pattern
nationwide
Recall initiation date
Aug 19, 2020
Initial firm notification
Letter
Center classification date
Aug 25, 2020

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1544-2020, published Sep 2, 2020. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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