Drug product
Acyclovir Tablets, USP, 400 mg, 50 Tablets (5 x 10) unit dose blisters [NDC 50268-061-11] per carton [NDC 50268-061-15], Rx Only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478
D-0544-2018
Product summary
- Firm
- Apace KY LLC
- Event
- Event 79194
- Status
- Terminated
- Classification
- Class II
- Quantity
- 630 cartons
- Official record key
drug-enforcement:D-0544-2018
Official wording
Reason: Presence of Foreign Tablet/Capsule; cartons labeled to contain Acyclovir tablets may contain Torsemide tablets in some of the blister cavities.
Code information: Lot: 19900, exp 05/2019
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Foreign Tablet