Mylan Recalls Diltiazem HCl Extended-Release Capsules Due to Impurities
Mylan Pharmaceuticals is recalling Diltiazem HCl Extended-Release Capsules because of out-of-specification results for a known compound.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which the rubric defines as typically resulting in a score of 1 or 2 because adverse health consequences are unlikely.
Plain-English summary
Mylan Pharmaceuticals Inc. is recalling Diltiazem HCl Extended-Release Capsules, USP 120 mg. The affected products are available in 100-count and 500-count bottles and are prescription-only. The recall covers approximately 51,983 capsules distributed nationwide.
The recall was initiated due to failed impurities and degradation specifications, specifically out-of-specification (OOS) results for a known compound. The agency has classified this recall as Class III, indicating that there is a remote possibility that adverse health consequences may be serious or permanently life-threatening, or that adverse health consequences are not likely to occur.
Consumers and healthcare providers should stop using the affected lots and return them to the pharmacy or point of purchase for a refund or replacement. Specific lot numbers and expiration dates are listed in the official recall notice.
The recalled product
- Product
- Diltiazem HCl Extended-release Capsules, USP 120 mg, 100-count bottle (NDC 0378-5220-01), 500-count bottle (NDC 0378-5220-05), Rx Only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV, 26505 USA
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Category
- Drug — Cardiovascular
- Hazard
- Affected units
- 51,983
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 (6)
- 0378-5220-01 Lot# 3065133
- Exp. 03/17 0378-5220-01 Lot# 3066564
- Exp. 05/17 0378-5220-05 Lot# 3066564
- Exp. 05/17 0378-5220-01 Lot# 3069645
- Exp. 08/17 0378-5220-05 Lot# 3069645
- Exp. 08/17
Distribution
Distributed nationwide across the United States.
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