Recalls / Class III
Class IIID-0391-2019
Product
LOPERAMIDE HCL TABLETS USP, 2 mg, ANTI-DIARRHEAL, 24 caplets per carton, OTC, Distributed by Drug Mart-Food Fair Medina Ohio 44256 Ohm Laboratories Inc. UPC 0 93351 11270 6 NDC#:53943-123-24
- Brand name
- Loperamide Hydrochloride
- Generic name
- Loperamide Hydrochloride
- Active ingredient
- Loperamide Hydrochloride
- Route
- Oral
- NDC
- 53943-123
- FDA application
- ANDA074091
- Affected lot / code info
- Lot: 2979325, EXP 5/5021
Why it was recalled
Labeling Not Elsewhere Classified: The front panel indicates 24 caplets whereas the side panel indicates 12 caplets. The drug product carton contains 24 caplets.
Recalling firm
- Firm
- Sun Pharmaceutical Industries, Inc.
- Manufacturer
- Discount Drug Mart
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 270 Prospect Plains Rd, N/A, Cranbury, New Jersey 08512-3605
Distribution
- Quantity
- 5040 cartons
- Distribution pattern
- OH
Timeline
- Recall initiated
- 2018-12-26
- FDA classified
- 2019-01-23
- Posted by FDA
- 2019-01-30
- Terminated
- 2020-04-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0391-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.