Allergan Recalls One Lot of Viokace Tablets Due to Stability Testing Failures
Allergan is recalling one lot of Viokace tablets because stability testing results did not meet specifications for enzyme profile.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a temporary or medically reversible adverse health consequence. The source text does not report any illnesses or injuries, and the hazard is a failure to meet specifications rather than a high-risk pathogen or structural defect.
Plain-English summary
Allergan USA Inc. is recalling one lot of Viokace (pancrelipase) tablets, 20,880 USP units, 100-count bottles. The recall involves 12,699 bottles distributed nationwide in the U.S. The specific lot number is 160741A, with an expiration date of 02/18.
The recall was initiated because product stability testing results did not meet the specifications for enzyme profile. This is classified as a subpotent drug recall.
Consumers and healthcare providers should check their inventory for this specific lot number and expiration date. If found, the product should be returned to the pharmacy or supplier for replacement or refund.
The recalled product
- Product
- Viokace (pancrelipase) tablets, 20,880 USP units, 100-count bottle, Rx only, Distributed by; Allergan USA Inc., Irvine, CA 92612, Manufactured in Canada, NDC 58914-117-10
- Manufacturer
- ALLERGAN
- Category
- Drug — Prescription Medication
- Affected units
- 12,699
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 #: 160741A
- Exp 02/18
Distribution
Distributed nationwide across the United States.
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