Teva Recalls Matzim LA Tablets Due to GMP Deviation
Teva Pharmaceuticals USA is recalling 5,849 bottles of Matzim LA (Diltiazem Hydrochloride) 240 mg tablets because the lot was not intended for commercial distribution.
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 by definition is unlikely to cause adverse health consequences. The issue is a GMP deviation regarding distribution intent rather than a direct safety hazard like contamination or mislabeling.
Plain-English summary
Teva Pharmaceuticals USA is recalling 5,849 bottles of Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 240 mg, 30 count. The affected product is identified by Lot # 1344864A and has an expiration date of 10/2020. The product is a prescription-only medication manufactured by Actavis Laboratories FL, Inc., and distributed by Actavis Pharma, Inc.
The recall was initiated due to a Good Manufacturing Practice (GMP) deviation. Specifically, the lot was not intended for commercial distribution. The FDA has classified this recall as Class III, which indicates that use of or exposure to the violative product is not likely to cause adverse health consequences.
The product was distributed to 42 wholesalers and 11 retailers, who may have further distributed the product throughout the United States, including Hawaii and Puerto Rico. Consumers and healthcare providers should check their inventory for the specific lot number and expiration date listed above. If the product is found, it should be returned to the pharmacy or distributor for credit or disposal.
The recalled product
- Product
- MATZIM LA (DILTIAZEM HYDROCHLORIDE)
- Brand
- MATZIM LA
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 5,849
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 # 1344864A
- exp. date 10/2020
Distribution
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