The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1229-2014·Announced 2014-04-16

Glenmark Recalls Ranitidine Tablets Due to Foreign Metoprolol Contamination

Glenmark Generics Inc. is recalling specific bottles of Ranitidine Tablets USP 150 mg because they were found to contain foreign Metoprolol Tartrate tablets.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, FDA Class II recalls with potential for significant injury or hospitalization (implied by the presence of a different active pharmaceutical ingredient) are rated as Severe.

Plain-English summary

Glenmark Generics Inc. is recalling 2,904 bottles of Ranitidine Tablets USP, 150 mg, 500-count bottles. The recall is limited to Lot 12AN118A with an expiration date of 10/14. The product was distributed nationwide.

The recall was initiated after a pharmacist reported finding a "foreign material" in a bottle of Ranitidine. The foreign material was identified as a Metoprolol Tartrate Tablet USP 50 mg that was co-mingled with the Ranitidine tablets.

Consumers should check their medication for the specific lot number and expiration date listed above. If the product matches the recalled lot, consumers should stop using it and contact their pharmacist or healthcare provider for guidance.

The recalled product

Product
Ranitidine Tablets USP, 150 mg, 500-count bottles, Rx only, Manufactured by: Shasun Pharmaceuticals Limited, Unit-II R.S. No 32 33 & 34, Shasun Road, Periyakalapet, Puducherry, - 605 014, India; Manufactured for: Glenmark Generics Inc, USA, Mahwah, NJ 07430, UPC 3 68462 24805 8…
Manufacturer
Glenmark Generics Inc., USA
Category
Drug — Prescription Medication
Hazard
Affected units
2,904

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 12AN118A
  • Exp 10/14

Distribution

Distributed nationwide across the United States.

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