Caraco Recalls Tramadol Tablets Due to Foreign Metoprolol Contamination
Caraco is recalling Tramadol HCl 50 mg tablets because a customer reported finding Metoprolol Tartrate tablets in a bottle.
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 adverse health consequences (such as receiving the wrong medication) are rated as Severe (4).
Plain-English summary
Caraco Pharmaceutical Laboratories, Ltd. is recalling 2,264 bottles of Tramadol Hydrochloride Tablets, USP 50 mg (NDC 57664-377-18). The recall was initiated after a customer complaint indicated that a bottle of Tramadol contained some tablets of Metoprolol Tartrate Tablets, USP, 50 mg.
The affected product is Lot # GKK1373 with an expiration date of 09/13. The tablets were manufactured by Sun Pharmaceuticals Industries in India and distributed by Caraco Pharmaceutical Laboratories in Detroit, Michigan. The distribution pattern for the recalled units is nationwide.
Consumers who have this product should stop using it and contact their pharmacist or Caraco Pharmaceutical Laboratories for instructions on how to return the product. The FDA classifies this recall as Class II, indicating a reasonable probability that the use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- traMADOL Hydrochloride Tablets, USP 50 mg, 1000-count tablets per bottle, Manufactured by: Sun Pharmaceuticals Industries, Dadra 396 191, India; Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijah McCoy Drive, Detroit, MI 48202; NDC 57664-377-18.
- Manufacturer
- Caraco Pharmaceutical Laboratories, Ltd.
- Category
- Drug — Prescription Medication
- Affected units
- 2,264
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 # GKK1373
- Exp 09/13
Distribution
Distributed nationwide across the United States.
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