Sandoz Recalls Tacrolimus Capsules Due to Fluvastatin Cross-Contamination
Sandoz Incorporated is recalling specific lots of Tacrolimus Capsules because trace amounts of fluvastatin were found in the product.
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 identifies the agency classification as Class II. According to the severity rubric, an FDA Class II recall corresponds to a score of 4 (Severe).
Plain-English summary
Sandoz Incorporated is recalling 12,521 bottles of Tacrolimus Capsules, USP, 0.5 mg. The affected product is a prescription-only medication manufactured in India by Sandoz Private Ltd. for Sandoz Inc. The recall covers lots DE9898, DE9900, DE9903, DE9908, and DE9911, all with an expiration date of 06/14.
The recall was initiated due to cross-contamination with other products. Specifically, findings indicated the carryover of trace amounts of fluvastatin, a previously manufactured product, into the Tacrolimus capsules. The affected products were distributed nationwide.
Consumers and healthcare providers should stop using the affected lots and contact their healthcare provider for guidance. The FDA classifies this recall as Class II, which means the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- TACROLIMUS (TACROLIMUS)
- Brand
- TACROLIMUS
- Manufacturer
- Sandoz Incorporated
- Category
- Drug — Prescription Drug
- Affected units
- 12,521
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 (5)
- Lots DE9898
- DE9900
- DE9903
- DE9908
- DE9911. Exp. 06/14
UPCs (3)
- 0307812103012
- 0307812102015
- 0307812104019
Distribution
Distributed nationwide across the United States.
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