Mylan Recalls Metoprolol Succinate Tablets Due to Foreign Object Presence
Mylan Pharmaceuticals is recalling 15,966 bottles of Metoprolol Succinate Extended-release Tablets 50mg because a pharmacist reported finding a rogue tablet of different size and markings 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, which corresponds to a 'Severe' severity score (4) according to the rubric, as it involves a potential risk of serious temporary or medically reversible adverse health consequences.
Plain-English summary
Mylan Pharmaceuticals Inc. is recalling 15,966 bottles of Metoprolol Succinate Extended-release Tablets, USP 50mg, 90-count bottles. The recall was initiated after a pharmacist reported the presence of a rogue tablet of different size and markings in a bottle of the medication. The affected product is identified by Lot 3023805 with an expiration date of 11/15 and NDC 0378-4596-77.
The recall is classified as FDA Class II. The product was distributed nationwide. Consumers and healthcare providers should check their inventory for bottles matching the specific lot number and expiration date listed above. If the product is found, it should be returned to the pharmacy or point of purchase for a refund or replacement.
The recalled product
- Product
- Metoprolol Succinate Extended-release Tablets, USP 50mg, 90-count Bottles, Rx only, Mfg by Mylan Pharmaceuticals, Inc. Morgantown, WV 26505. NDC 0378-4596-77.
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 15,966
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 (1)
- Lot 3023805 Exp. 11/15
Distribution
Distributed nationwide across the United States.
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