PlainRecordsFDA · Drug recall
Acyclovir Tablets…
- Date
- March 7, 2018
- Risk class
- Class II (FDA's definition, 21 CFR 7.3(m): 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)
- Status
- Terminated
- Filed by
- Apace KY LLC
- 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
- Reason
- Presence of Foreign Tablet/Capsule; cartons labeled to contain Acyclovir tablets may contain Torsemide tablets in some of the blister cavities.
- Distribution pattern
- Nationwide
- Quantity
- 630 cartons
- Codes and lots
- Lot: 19900, exp 05/2019
- Recall started
- Feb. 9, 2018
- Recall number
- D-0544-2018
What should I do? Medicine recall: what to do
Source: FDA · Drug enforcement report, recall number D-0544-2018. The agency record governs; check it and the company before acting.