Why it was recalled
SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent
Product description
diphenoxylate hydrochloride and atropine sulfate tablets, USP, 2.5 mg/0.025 mg, a) 100-count bottle (NDC 59762-1061-1), b) 1000-count bottle (NDC 59762-1061-2), Rx Only, Distributed by: Greenstone LLC. Peapack, NJ 07977
Lot numbers, UPCs & expiration codes
Lots: a) R83962, R93347, R93348, R93349, R93350, R93351, R93352, Exp. 2021 OCT 31; S57831, S57832, S57834, Exp. 2021 NOV 30 b) R93356, R93357, R93358, R97310, Exp. 2021 OCT 31.
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0150-2018
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Oct 20, 2017
- FDA report date
- Jan 10, 2018
- Quantity
- 183437 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pfizer Inc.
Original FDA data
Every field from FDA enforcement report D-0150-2018, exactly as published.
Show all FDA fields
- City
- New York
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 78332
- Address
- 235 E 42nd St
- Code information
- Lots: a) R83962, R93347, R93348, R93349, R93350, R93351, R93352, Exp. 2021 OCT 31; S57831, S57832, S57834, Exp. 2021 NOV 30 b) R93356, R93357, R93358, R97310, Exp. 2021 OCT 31.
- Postal code
- 10017-5703
- Report date
- Jan 10, 2018
- Product type
- Drugs
- Recall number
- D-0150-2018
- Classification
- Class I
- Recalling firm
- Pfizer Inc.
- Product quantity
- 183437 bottles
- Termination date
- Jun 2, 2020
- Reason for recall
- SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- diphenoxylate hydrochloride and atropine sulfate tablets, USP, 2.5 mg/0.025 mg, a) 100-count bottle (NDC 59762-1061-1), b) 1000-count bottle (NDC 59762-1061-2), Rx Only, Distributed by: Greenstone LLC. Peapack, NJ 07977
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Oct 20, 2017
- Initial firm notification
- Letter
- Center classification date
- Jan 4, 2018