Recalls / Class II
Class IID-0544-2018
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
- Brand name
- Acyclovir
- Generic name
- Acyclovir
- Active ingredient
- Acyclovir
- Route
- Oral
- NDCs
- 50268-061, 50268-062
- FDA application
- ANDA075382
- Affected lot / code info
- Lot: 19900, exp 05/2019
Why it was recalled
Presence of Foreign Tablet/Capsule; cartons labeled to contain Acyclovir tablets may contain Torsemide tablets in some of the blister cavities.
Recalling firm
- Firm
- Apace KY LLC
- Manufacturer
- AvPAK
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 12954 Fountain Run Rd, N/A, Fountain Run, Kentucky 42133-7914
Distribution
- Quantity
- 630 cartons
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2018-02-09
- FDA classified
- 2018-02-23
- Posted by FDA
- 2018-03-07
- Terminated
- 2019-09-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0544-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.