Metformin Hydrochloride Extended-Release Tablets USP, 500 mg 1000 Tablets Rx Only Manufactured by: Beximco Pharmaceuticals, LTD. 126, Kathaldia, Tongi, Gazipur, 1711, Bangladesh NDC 76385-128-10
Reported: September 2, 2020 Initiated: August 19, 2020 #D-1543-2020
Product Description
Metformin Hydrochloride Extended-Release Tablets USP, 500 mg 1000 Tablets Rx Only Manufactured by: Beximco Pharmaceuticals, LTD. 126, Kathaldia, Tongi, Gazipur, 1711, Bangladesh NDC 76385-128-10
Reason for Recall
CGMP Deviations
Details
- Recalling Firm
- BAYSHORE PHARMACEUTICALS
- Units Affected
- 594 bottles
- Distribution
- nationwide
- Location
- Short Hills, NJ
Frequently Asked Questions
What product was recalled? ▼
Metformin Hydrochloride Extended-Release Tablets USP, 500 mg 1000 Tablets Rx Only Manufactured by: Beximco Pharmaceuticals, LTD. 126, Kathaldia, Tongi, Gazipur, 1711, Bangladesh NDC 76385-128-10. Recalled by BAYSHORE PHARMACEUTICALS. Units affected: 594 bottles.
Why was this product recalled? ▼
CGMP Deviations
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 2, 2020. Severity: Moderate. Recall number: D-1543-2020.
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