Why it was recalled
Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C (68¿F to 77¿F).
Product description
Clindamycin 300 mg capsules, USP, 28-count M-Pak containers, Rx Only. Mnfct for: Lannett Co. Inc., Philadelphia, PA 19136. Mnfct. by: Lannett Co. Inc., Philadelphia, PA 19136. Pckgd by PreScript Pharm. Inc., Pleasanton, CA 94566. NDC: 00527-1383-01, Bar Code 0784-28-11
Lot numbers, UPCs & expiration codes
Lot # 0130132, EXP 3/31/19
Where it was sold
California.
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-0808-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 24, 2018
- FDA report date
- May 23, 2018
- Quantity
- 5 28-count containers
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Prescript Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0808-2018, exactly as published.
Show all FDA fields
- City
- Pleasanton
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 79961
- Address
- 39 California Ave Ste 104
- Code information
- Lot # 0130132, EXP 3/31/19
- Postal code
- 94566-6279
- Report date
- May 23, 2018
- Product type
- Drugs
- Recall number
- D-0808-2018
- Classification
- Class II
- Recalling firm
- Prescript Pharmaceuticals, Inc.
- Product quantity
- 5 28-count containers
- Termination date
- Jan 23, 2019
- Reason for recall
- Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C (68¿F to 77¿F).
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Clindamycin 300 mg capsules, USP, 28-count M-Pak containers, Rx Only. Mnfct for: Lannett Co. Inc., Philadelphia, PA 19136. Mnfct. by: Lannett Co. Inc., Philadelphia, PA 19136. Pckgd by PreScript Pharm. Inc., Pleasanton, CA 94566. NDC: 00527-1383-01, Bar Code 0784-28-11
- Distribution pattern
- California.
- Recall initiation date
- Apr 24, 2018
- Initial firm notification
- Letter
- Center classification date
- May 14, 2018