The Recall Desk
SevereFDA (Drugs)·D-1544-2020·Announced 2020-09-02

Bayshore Pharmaceuticals Recalls Metformin Hydrochloride Tablets Due to CGMP Deviations

Bayshore Pharmaceuticals is voluntarily recalling 3,984 bottles of Metformin Hydrochloride Extended-Release Tablets due to Current Good Manufacturing Practice (CGMP) deviations.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source text explicitly states the agency classification is Class II. According to the rubric, if the agency's own classification is FDA Class I or USDA Class I, the score is never below 4. Since this is FDA Class II, and the rubric maps Class II with potential for adverse health consequences to the 'Severe' tier (Score 4) in the absence of specific hospitalization reports which would also be 4, or if it were Class I which is 5, the score is set to 4 to reflect the 'Severe' label associated with Class II classifications in the provided mapping logic where Class I is Critical (5) and Class II is Severe (4).

Plain-English summary

Bayshore Pharmaceuticals has initiated a voluntary recall of 3,984 bottles of Metformin Hydrochloride Extended-Release Tablets USP, 750 mg. The affected product is identified by Lot #18657 and has an expiration date of 05/2021. The tablets are manufactured by Beximco Pharmaceuticals, LTD. in Bangladesh and are distributed nationwide.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. The FDA has classified this recall as Class II, which indicates a situation that may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. The recall was initiated on August 19, 2020, and was terminated on April 26, 2021.

Consumers who have this specific lot of medication should stop using it and contact their healthcare provider or pharmacist for guidance on obtaining a replacement. The recall was initiated by the firm and notified via letter.

The recalled product

Product
METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
Brand
METFORMIN HYDROCHLORIDE
Manufacturer
BAYSHORE PHARMACEUTICALS
Category
Drug — Prescription Medication
Hazard
Affected units
3,984

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot #18657
  • Exp. 05/2021

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by BAYSHORE PHARMACEUTICALS under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same brand · METFORMIN HYDROCHLORIDE

Same manufacturer · BAYSHORE PHARMACEUTICALS

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Same hazard · cgmp deviations

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