Drug product
GILTUSS ANTITUSSIVE EXPECTORANT AND NASAL DECONGESTANT, 1 fl. oz. (NDC 58552-122-01) and 8 fl. oz. (NDC 58552-122-08), and EXACTUSS ANTITUSSIVE EXPECTORANT AND NASAL DECONGESTANT, 16 fl. oz. (NDC 58552-125-16) --- Manufactured for: GIL PHARMACEUTICAL CORP. PONCE, PUERTO RICO 00716
D-66207-001
Product summary
- Event
- Event 66207
- Status
- Terminated
- Classification
- Class III
- Quantity
- 50,848 bottles (total for 3 lots)
- Official record key
drug-enforcement:D-66207-001
Official wording
Reason: Subpotent; phenylephrine HCl
Code information: 1 fl. oz. and 8 fl. oz.: Batch/Lot 615688 (exp. 06/2014) and Batch/Lot 617689 (exp. 11/2014); 16 fl. oz: Batch/Lot 615649 (exp. 05/2014).
Distribution pattern: Puerto Rico
Derived failure modes
-
Potency or specification failure
Subpotent